Devices, systems and methods useable for treating sinusitis

• US 8,715,169 B2
• Filed: 10/30/2007
• Issued: 05/06/2014
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Chang, John Y., Makower, Joshua, Vrany, Julia D., Morriss, John H., Muni, Ketan P., Kim, Isaac J., Ha, Hung, Facteau, William M., Walke, Amrish Jayprakash
• Primary Examiner(s): Nia, Alireza
• Application Number:
  US11/928,097
• Publication Number:
  US 20080125626A1
• Time in Patent Office: 2,380 Days
• Field of Search: 600/104, 600114-116, 606/196
• US Class Current: 600/116
• CPC Class Codes: A61B 1/233 for the nose, i.e. nasoscopes , e.g. testing of patency of Eustachian tubes
• CPC Class Codes: A61B 17/12104 in an air passage
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/1657 Bone breaking devices
• CPC Class Codes: A61B 17/1688 for the sinus or nose
• CPC Class Codes: A61B 17/24 for use in the oral cavity, larynx, bronchial passages or nose for medical inspection of cavities or tubes in the body A61B1/00; Tongue scrapers
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/246 for cleaning of the nose
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/3764 with a rotating C-arm having a cone beam emitting source
• CPC Class Codes: A61B 2503/40 Animals
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2029/025 characterised by the guiding element
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2210/1028 Larynx
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0054 : with regions for increasing flexibility
• CPC Class Codes: A61M 25/0662 : Guide tubes
• CPC Class Codes: A61M 25/09 : Guide wires
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 29/00 : Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Sinusitis and other disorders of the ear, nose and throat are diagnosed and/or treated using minimally invasive approaches with flexible or rigid instruments. Various methods and devices are used for remodeling or changing the shape, size or configuration of a sinus ostium or duct or other anatomical structure in the ear, nose or throat; implanting a device, cells or tissues; removing matter from the ear, nose or throat; delivering diagnostic or therapeutic substances or performing other diagnostic or therapeutic procedures. Introducing devices (e.g., guide catheters, tubes, guidewires, elongate probes, other elongate members) may be used to facilitate insertion of working devices (e.g. catheters e.g. balloon catheters, guidewires, tissue cutting or remodeling devices, devices for implanting elements like stents, electrosurgical devices, energy emitting devices, devices for delivering diagnostic or therapeutic agents, substance delivery implants, scopes etc.) into the paranasal sinuses or other structures in the ear, nose or throat. Specific devices (e.g., tubular guides, guidewires, balloon catheters, tubular sheaths) are provided as are methods for manufacturing and using such devices to treat disorders of the ear, nose or throat.

Claims

1. A method for dilating, in a human or animal subject, an opening of a paranasal sinus, wherein the opening comprises comprising a natural ostium, man-made hole or outflow tract which leads into the interior of a paranasal sinus cavity and which is surrounded by bone covered by mucosa, said method comprising the steps of:

a) providing a dilation device that comprises an elongate shaft and a dilator;

the elongate shaft having at least one deformable region proximal to the dilator and at least one substantially stiff region that is proximal to the deformable region, said at least one deformable region being deformable to a deformed configuration that facilitates subsequent insertion of the elongate shaft through the subject'"'"'s nose to a position where the dilator is within the paranasal sinus opening to be dilated;

b) deforming the deformable region to said deformed configuration;

c) after deformation of the deformable region to said deformed configuration, inserting the elongate shaft through the subject'"'"'s nose to a position where the dilator is within the paranasal sinus opening to be dilated;

d) causing the dilator of the dilation device to dilate the paranasal sinus opening within which it is positioned causing breakage of bone, and

e) removing the dilation device.

2. A method according to claim 1 wherein the elongate shaft comprises a substantially stiff distal region on which the dilator is located, a substantially stiff proximal region and a deformable region located between the substantially stiff proximal and distal regions.

3. A method according to claim 1 wherein a substantially flexible region of the dilation device and a substantially rigid region of the dilation device are in substantially fixed positions with respect to each other.

4. A method according to claim 1 wherein at least one of i) a substantially flexible region of the dilation device and ii) a substantially rigid region of the dilation device is caused to move with respect to the other.

5. A method according to claim 1 wherein the elongate shaft further comprises a lumen and wherein the method further comprises the step of suctioning matter through the lumen of the elongate shaft.